UMIN-CTR Clinical Trial

Basic information
Public title	Usefulness of gastritis evaluation by image-enhanced endoscopy: Randomized controlled trial
Acronym	Usefulness of gastritis evaluation by image-enhanced endoscopy: Randomized controlled trial
Scientific Title	Usefulness of gastritis evaluation by image-enhanced endoscopy: Randomized controlled trial
Scientific Title:Acronym	Usefulness of gastritis evaluation by image-enhanced endoscopy: Randomized controlled trial
Region	Japan

Condition
Condition	Patients receiving upper gastrointestinal endoscopy
Classification by specialty	Medicine in general Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	(1) To clarify appropriate observation method for evaluation of findings including gastric mucosal atrophy and intestinal metaplasia by image-enhanced endoscope (2) To clarify efficacy of the evaluation of gastric lesions between image-enhanced endoscopes and white-light endoscopy.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Comparison of white light and image-enhanced endoscopy in diagnostic ability by gastritis findings
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	4
Purpose of intervention	Diagnosis
Type of intervention	Maneuver
Interventions/Control_1	Endoscopy 1. White light-narrow band imaging
Interventions/Control_2	2. White light-TXI
Interventions/Control_3	3. narrow band imaging-White light
Interventions/Control_4	4. TXI-white light
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Those who are 20 years of age or older and have consented to participate in this study by signing a consent form from the person himself / herself.
Key exclusion criteria	1. Those who did not agree to participate in this study 2. Those with serious complications (heart failure, liver failure, respiratory failure) 3. Pregnant or lactating 4. Others who are judged to be inappropriate for participating in this study
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Mitsushige Middle name Last name Sugimoto
Organization	Tokyo Medical University Hospital
Division name	Department of Gastroenterological Endoscopy
Zip code	160-0023
Address	6-7-1, Nishishinjuku, Shinjuku-ku, Tokyo,
TEL	03-3342-6111
Email	sugimo@tokyo-med.ac.jp

Public contact
Name of contact person	1st name Mitsushige Middle name Last name Sugimoto
Organization	Tokyo Medical University Hospital
Division name	Department of Gastroenterological Endoscopy
Zip code	160-0023
Address	6-7-1, Nishishinjuku, Shinjuku-ku, Tokyo,
TEL	03-3342-6111
Homepage URL
Email	sugimo@tokyo-med.ac.jp

Sponsor
Institute	Tokyo Medical University Hospital
Institute
Department

Funding Source
Organization	Tokyo Medical University Hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Insitutional Review Board, Tokyo MEdical University
Address	6-7-1, Nishishinjuku, Shinjuku-ku, Tokyo
Tel	03-3342-6111
Email	IRB@tokyo-med.ac.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2021 Year 05 Month 09 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2021 Year 02 Month 02 Day
Date of IRB	2021 Year 02 Month 17 Day
Anticipated trial start date	2021 Year 04 Month 01 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 05 Month 09 Day
Last modified on	2021 Year 05 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050413